Monthly 100,000 IU of vitamin D decreased respiratory infection but increased falls
High-Dose Monthly Vitamin D for Prevention of Acute Respiratory Infection in Older Long-Term Care Residents: A Randomized Clinical Trial
Journal of the American Geriatrics Society, First published: 16 November 2016, DOI: 10.1111/jgs.14679
Adit A. Ginde MD, MPH, Patrick Blatchford PhD, Keith Breese MA, Lida Zarrabi MPH,
Sunny A. Linnebur PharmD, Jeffrey I. Wallace MD, MPH, Robert S. Schwartz MD
Objectives: To determine the efficacy and safety of high-dose vitamin D supplementation for prevention of acute respiratory infection (ARI) in older long-term care residents.
Design: Randomized controlled trial investigating high-dose vs standard-dose vitamin D from 2010 to 2014.
Setting: Colorado long-term care facilities.
Participants: Long-term care residents aged 60 and older (n = 107).
Intervention: The high-dose group received monthly supplement of vitamin D3 100,000 IU, the standard-dose group received a monthly placebo (for participants taking 400–1,000 IU/d as part of usual care) or a monthly supplement of 12,000 IU of vitamin D3 (for participants taking <400 IU/d as part of usual care).
Measurements: The primary outcome was incidence of ARI during the 12-month intervention.
Secondary outcomes were falls and fractures, 25-hydroxyvitamin D levels, hypercalcemia, and kidney stones.
Results: Participants (55 high dose, 52 standard dose) were randomized and included in the final analysis.
The high-dose group had 0.67 ARIs per person-year and the standard-dose group had 1.11 (incidence rate ratio (IRR) = 0.60, 95% confidence interval (CI) = 0.38–0.94, P = .02).
Falls were more common in the high-dose group (1.47 per person-year vs 0.63 in standard-dose group; IRR = 2.33, 95% CI = 1.49–3.63, P < .001).
Fractures were uncommon and similar in both groups (high dose 0.10 vs standard dose 0.19 per person-year; P = .31).
Mean trough 25-hydroxyvitamin D levels during the trial were 32. ng/mL in the high-dose group and 25.1 ng/mL in the standard-dose group.
There was no hypercalcemia or kidney stones in either group.
Conclusion: Monthly high-dose vitamin D3 supplementation reduced the incidence of ARI in older long-term care residents but was associated with a higher rate of falls without an increase in fractures.
Table from study
|
System Organ Class |
High Dose |
Standard Dose |
|
|
n (%) |
|
|
Blood and lymphatic system disorders |
7 (13) |
4 (8) |
|
Cardiac disorders |
15 (27) |
9 (17) |
|
Dermal and epidermal conditions |
0 (0) |
0 (0) |
|
Ear and labyrinth disorders (cause falls?) |
6 (11) |
1 (2) |
|
Endocrine disorders |
3 (5) |
0 (0) |
|
Eye disorders (fewer) |
5 (9) |
7 (13) |
|
Gastrointestinal disorders (fewer) |
22 (40) |
27 (52) |
|
General disorders and administration site conditions |
39 (71) |
28 (54) |
|
Hepatobiliary disorders |
1 (2) |
1 (2) |
|
Immune system disorders |
9 (16) |
7 (13) |
|
Infections and infestations |
21 (38) |
21 (40) |
|
Injury, poisoning, and procedural complications |
29 (53) |
30 (58) |
|
Investigations |
16 (29) |
12 (23) |
|
Metabolic, nutritional, and blood gas investigations |
18 (33) |
15 (29) |
|
Musculoskeletal and connective tissue disorders |
17 (31) |
16 (31) |
|
Neoplasms benign, malignant, and unspecified |
1 (2) |
1 (2) |
|
Nervous system disorders |
10 (18) |
10 (19) |
|
Neuromuscular disorders |
1 (2) |
0 (0) |
|
Ocular infections, irritations, and inflammations |
0 (0) |
0 (0) |
|
Psychiatric disorders |
30 (55) |
19 (37) |
|
Renal and urinary disorders |
13 (24) |
10 (19) |
|
Reproductive systems and breast disorders |
6 (11) |
2 (4) |
|
Respiratory, thoracic, and mediastinal disorders |
24 (44) |
30 (58) |
|
Skin and subcutaneous tissue disorders |
23 (42) |
22 (42) |
|
Social circumstances |
1 (2) |
0 (0) |
|
Surgical and medical procedures |
14 (25) |
6 (12) |
|
Vascular disorders |
0 (0) |
0 (0) |
|
Total with ≥1 adverse events |
53 (96) |
49 (94) |